Z-0138-2022 Class II Terminated
FDA device recall Z-0138-2022 was initiated by GE Healthcare, LLC on August 26, 2021 and is designated Class II. Reason for recall: Under certain conditions, some slices may be missing which can lead to a gap of anatomy in the 3D Volume images. The recall status is terminated (terminated May 4, 2026). Affected quantity: 15 devices.
Recall Details
- Product Type
- Devices
- Report Date
- October 27, 2021
- Initiation Date
- August 26, 2021
- Termination Date
- May 4, 2026
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 15 devices
Product Description
SIGNA Voyager nuclear magnetic resonance imaging system
Reason for Recall
Under certain conditions, some slices may be missing which can lead to a gap of anatomy in the 3D Volume images.
Distribution Pattern
Distribution in United States to AZ, CA, FL, GA, IL, LA, MA, MD, MN, NC, NH, NJ, NY, OH, OK, TX, VA, WA, and Puerto Rico OUS distribution to: Australia, Belgium, Canada, Chile, Colombia, France, Germany, Italy, Japan, Korea, Poland, Saudi Arabia, Spain, Sweden, Turkey, UAE, and UK
Code Information
Software version VX29.1; and PX26.4 (China only)